Search Results for: Come si esegue la raccolta delle urine delle 24 ore

Introduction
Prompt recognition and treatment of patients with sepsis improve survival. Patients transported to hospital with sepsis often do not receive treatment until they are assessed in emergency departments. Initiation of treatments by paramedics at the point of first contact may improve outcomes for these patients.

Methods and analysis
The study design involves two randomised controlled trials (RCTs) conducted using a 2×2 factorial design comparing use of (1) early intramuscular ceftriaxone versus placebo and (2) an early liberal intravenous fluid strategy (up to 2 L normal saline) versus usual care resuscitation guided by paramedic medical directives. Patients who are ≥18 years of age will be eligible for inclusion if they have sepsis, defined as (1) paramedic suspicion of infection, (2) fever (temperature ≥38.0°C measured by paramedic or history of fever during the previous 24 hours), and (3) hypotension: SBP 250 mL) within 24 hours of hospital arrival; total amount of crystalloid infused during transport and first 24 hours of hospitalisation; and proportion of enrolled patients not suspected to have sepsis or infection by emergency department physicians. Safety outcomes include the proportion of patients with pulmonary oedema during transport to hospital and on initial chest X-ray and the proportion of patients with anaphylaxis or suspected allergic reactions to study medication.

Ethics and dissemination
This study has been approved through Clinical Trials Ontario’s streamlined ethics review process (board of record, Sunnybrook Health Sciences Centre). It will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and regulatory requirements. The final results will be disseminated to participating paramedic services through educational materials, presentations and interactive training. We anticipate our trial will achieve wide dissemination through publication in a peer-reviewed medical journal and presentation at international conferences targeting the fields of prehospital and emergency medicine, resuscitation and critical care.

Trial registration number
NCT03068741.

Background
Musculoskeletal injury (MSKI) is the leading cause of medical downgrading and discharge within the UK military, with lower limb MSKI having the greatest incidence, negatively impacting operational readiness. Pain is a primary limiting factor to rehabilitation progress following MSKI. Heavy-load resistance training (RT; ie, loads >70% 1-repetition maximum) is traditionally used but may be contraindicated due to pain, potentially prolonging recovery and leading to failure of essential physical employment standards for UK military personnel. Low-load RT with blood flow restriction (BFR) can promote favourable morphological and physiological adaption, as well as elicit hypoalgesia in healthy and clinical populations (eg, post-operative), and has proven a viable option in military rehabilitation settings. The acceptability and tolerance of higher relative BFR pressures in persistent pain populations are unknown due to the complexity of presentation and the perception of discomfort experienced during BFR exercise. Greater relative pressures (ie, 80% limb occlusion pressure (LOP)) elicit a greater hypoalgesic response in pain-free individuals, but greater perceived discomfort which may not be tolerated in persistent pain populations. However, lower relative pressure (ie, 40% LOP) has elicited hypoalgesia in pain-free individuals, which therefore may be more clinically acceptable and tolerated in persistent pain populations. The primary aim of both randomised controlled trials (RCT) is to investigate the efficacy and acceptability of using high-frequency, low-load BFR-RT in UK military personnel with lower limb MSKI where persistent pain is the primary limiting factor for progression.

Methodology
The presented protocol is a two-phase RCT based within a military rehabilitation setting. Phase One is a 1-week RCT to determine the most efficacious and acceptable BFR-RT protocol (7x BFR-RT sessions over 5 days at 40% or 80% LOP; n=28). Phase Two is a 3-week RCT comparing the most clinically acceptable BFR pressure, determined by Phase One (21x BFR-RT sessions over 15 days; n=26) to usual care within UK Defence Rehabilitation residential rehabilitation practices. Outcomes will be recorded at baseline, daily and following completion of the intervention. The primary outcome will be the brief pain inventory. Secondary outcomes include blood biomarkers for inflammation and pain (Phase Two only), injury-specific outcome measures, lower extremity function scale, objective measures of muscle strength and neuromuscular performance, and pressure pain threshold testing.

Ethics and dissemination
The study is approved by the Ministry of Defence Research Ethics Committee (2318/MODREC/24) and Northumbria University. All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.

Trial registration number
Registered with Clinical Trials. The registration numbers are as follows: NCT06621914 (Phase One) and NCT06621953 (Phase Two).

Since 2015, global foreign aid has provided nearly 40% of HIV-related funding in low- and middle-income countries. With an anticipated 24% reduction in international aid—in addition to the potential discontinuation of the US President’s Emergency Plan for AIDS Relief (PEPFAR)—a modeling study estimates that 4.4 million to 10.8 million additional HIV infections will occur by 2030.

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Introduction
Children discharged from hospital following management of complicated severe acute malnutrition (SAM) have a high risk of mortality, readmission and failed nutritional recovery. Current management approaches fail to sufficiently promote convalescence after inpatient nutritional rehabilitation. Novel interventions during the post-discharge period could enhance convalescence to help children survive and thrive.

Methods and analysis
The Co-SAM trial is an adaptive, multicountry, phase III, individually randomised clinical trial, based on the principles that (i) interacting biological and social factors drive multimorbidity in children with SAM, and (ii) both medical and psychosocial interventions may therefore ameliorate underlying causal pathways to reduce morbidity and mortality and improve recovery. Children aged 6–59 months with complicated SAM, who have stabilised and started the transition to ready-to-use therapeutic food (RUTF), will be enrolled and randomised to one of five trial arms (standard-of-care alone; antimicrobials; reformulated RUTF; psychosocial support; or a combination of all strategies). Standard-of-care, which is provided in all trial arms, includes RUTF until nutritional recovery (defined as weight-for-height Z-score >–2, mid-upper arm circumference >12.5 cm and oedema-free since the last study visit), and other management recommended in WHO guidelines. The 12-week antimicrobial package provides daily co-formulated rifampicin and isoniazid (with pyridoxine) and 3 days of azithromycin monthly. The reformulated RUTF, which incorporates medium-chain triglycerides and hydrolysed protein to increase nutrient bioavailability and reduce metabolic stress, is provided at the same dose and duration as standard RUTF. The 12-week psychosocial package includes caregiver problem-solving therapy, educational modules, peer support groups and child play. The combined arm includes all interventions. Children start their intervention package prior to hospital discharge, with follow-up data collection in study clinics at 2, 4, 6, 8, 12 and 24 weeks. The primary composite outcome is death, hospitalisation or failed nutritional recovery within 24 weeks post-randomisation. An interim analysis will allow unpromising arms to be dropped, while the final analysis will be conducted when 1266 children have completed the study. Embedded process evaluation and laboratory substudies will explore the mechanisms of action of the interventions.

Ethics and dissemination
The trial has been approved by ethics committees in Zimbabwe, Zambia, Kenya and UK. Dissemination will be via community advisory boards in each country; Ministries of Health; and dialogue with policymakers including UNICEF.

Trial registration number
Clinicaltrials.gov: NCT05994742; Pan African Clinical Trials Registry: PACTR202311478928378.

Purpose
The AMBulatoRy blOod preSsure In older Adults (AMBROSIA) study cohort was designed to determine whether ambulatory blood pressure (BP) monitoring (ABPM) is useful for identifying older adults with hypertension taking antihypertensive medication who are at increased risk for falls. The association of home BP monitoring (HBPM) with falls was assessed in an ancillary study (AMBROSIA-HOME).

Participants
AMBROSIA was a prospective observational study of adults aged 65 years and older taking antihypertensive medication for hypertension. Participants were recruited from Kaiser Permanente Southern California (KPSC), an integrated healthcare delivery system, and enrolled from May 2019 to November 2022. Demographic and clinical characteristics and geriatric assessments were collected over the course of two consecutive study visits. Participants completed a 24-hour ABPM and 1 week of HBPM. Over the following year, falls were assessed using a monthly falls calendar, and serious fall injuries were assessed from the KPSC electronic health record (EHR).

Findings to date
We enrolled 670 participants; 656 completed 24-hour ABPM and 536 also completed HBPM. The mean (SD) age of the AMBROSIA cohort was 75 (6) years, 16% were over 80 years of age and 56% were female. There were 13% non-Hispanic Asian or Pacific Islander, 22% non-Hispanic Black, 18% Hispanic and 44% non-Hispanic White participants. Nearly 72% had mild cognitive impairment, 50% were pre-frail and 4% were frail. Overall, 87% of participants returned all monthly calendars during follow-up.

Future plans
The AMBROSIA cohort can be updated with longitudinal data from the EHR including antihypertensive medication to explore the relationship of fall risk and white coat effect, defined as the difference between clinic BP and out-of-clinic BP, BP variability over 24 hours and postprandial BP decline with antihypertensive medication intensification during follow-up. Additionally, the cohort can be updated to include outcomes data from the EHR such as cardiovascular events to examine BP phenotypes as potential predictors of cardiovascular events.

Introduction
Physical activity (PA) is crucial for older adults’ well-being and mitigating health risks. Encouraging active lifestyles requires a deeper understanding of the factors influencing PA, which conventional approaches often overlook by assuming stability in these determinants over time. However, individual-level determinants fluctuate over time in real-world settings. Digital phenotyping (DP), employing data from personal digital devices, enables continuous, real-time quantification of behaviour in natural settings. This approach offers ecological and dynamic assessments into factors shaping individual PA patterns within their real-world context. This paper presents a study protocol for the DP of PA behaviour among community-dwelling older adults aged 65 years and above.

Methods and analysis
This 2-week multidimensional assessment combines supervised (self-reported questionnaires, clinical assessments) and unsupervised methods (continuous wearable monitoring and ecological momentary assessment (EMA)). Participants will wear a Garmin Vivosmart V.5 watch, capturing 24/7 data on PA intensity, step count and heart rate. EMA will deliver randomised prompts four times a day via the Smartphone Ecological Momentary Assessment3 application, collecting real-time self-reports on physical and mental health, motivation, efficacy and contextual factors. All measurements align with the Behaviour Change Wheel framework, assessing capability, opportunity and motivation. Machine learning will analyse data, employing unsupervised learning (eg, hierarchical clustering) to identify PA behaviour patterns and supervised learning (eg, recurrent neural networks) to predict behavioural influences. Temporal patterns in PA and EMA responses will be explored for intraday and interday variability, with follow-up durations optimised through random sliding window analysis, with statistical significance evaluated in RStudio at a threshold of 0.05.

Ethics and dissemination
The study has been approved by the ethical committee of Hasselt University (B1152023000011). The findings will be presented at scientific conferences and published in a peer-reviewed journal.

Trial registration number
NCT06094374.

Introduction
People living with HIV/AIDS (PLWHA) have complex physical, psychological, social and spiritual needs following diagnosis and poorer health-related quality of life than the general population. Holistic assessment and care delivery incorporating person-centred principles is required to address these needs. This protocol describes a cluster randomised controlled trial (cRCT) and process evaluation to evaluate the effectiveness of the extra community-based enhanced care intervention (ExtraCECI) to improve the quality of life and person-centred outcomes for PLWHA in Ghana.

Methods and analysis
This cRCT will randomly assign 26 recruited HIV clinics using 1:1 allocation to either ExtraCECI intervention or standard HIV care, with each clinic recruiting an average of 25 participants, that is, 650 in total. Eligible participants are adult PLWHA aged at least 18 years and in HIV care for at least 6 months, with cognitive ability to consent as guided by the Mental Capacity Act, clinically well to participate, attending an outpatient clinic. Healthcare professionals (HCP) at clinics randomised to the ExtraCECI intervention arm will receive training on person-centred care and holistic assessment of PLWHA in the domains of physical, psychological, social and spiritual well-being. PLWHA will be empowered to contribute to their care decisions including HCP using telehealth for ExtraCECI delivery with ongoing mentorship, while participants in the Standard HIV Care arm continue with usual care. The primary outcome is quality of life measured at the individual level using Medical Outcomes Study-HIV (MOS-HIV). The primary analysis will compare MOS-HIV total scores between groups using repeated measure linear mixed model and adjusting for important baseline characteristics (including stratification factors) and random effect of clinic. The incremental cost-effectiveness ratio will be used to estimate the cost-effectiveness of the ExtraCECI intervention, and a process evaluation will be conducted.

Ethics and dissemination
This protocol was approved by Edinburgh Napier University School of Health and Social Care Research Integrity Committee (REF: SHSC3681836) and the Ghana Health Service Ethics Review Committee (GHS-ERC:010/07/24). Results from this study whether positive or negative will be presented to participating sites, communities, at scientific conferences and published in peer-reviewed journals.

Trial registration number
ISRCTN77405303.

Stroke, Ahead of Print. BACKGROUND:There is uncertainty about whether patients with M2 occlusion benefit from endovascular therapy (EVT) in the late (6–24-hour) time window. We evaluated the clinical outcomes of patients with M2 occlusion selected for EVT compared with those who received medical management (MM) in the late window.METHODS:This multinational cohort study was conducted at 66 sites across 10 countries (January 2014 to May 2022). We included consecutive patients with late-window stroke due to M2 occlusion, baseline National Institutes of Health Stroke Scale score of ≥5, and premorbid modified Rankin Scale score of ≤2 who received EVT or MM alone. The primary end point was 90-day ordinal shift in the modified Rankin Scale score. Safety end points were symptomatic intracranial hemorrhage and 90-day mortality. Differences in outcomes were determined using inverse probability of treatment weighting–adjusted logistic regression models.RESULTS:Among 5098 patients, 496 met inclusion criteria (median [interquartile range] age, 74 years [62–81 years]; baseline National Institutes of Health Stroke Scale score, 12 [8–17]), of whom 394 (79.4%) received EVT and 102 (20.6%) MM. In inverse probability of treatment weighting adjusted analyses, there was no favorable 90-day ordinal modified Rankin Scale shift (odds ratio, 1.39 [95% CI, 0.92–2.12]) and no difference of functional independence rates (modified Rankin Scale score of 0–2; odds ratio, 1.72 [95% CI, 0.93–3.15]) with EVT compared with MM. Moreover, symptomatic intracranial hemorrhage risk (odds ratio, 3.46 [95% CI, 0.50–23.92]) and 90-day mortality (odds ratio, 1.11 [95% CI, 0.66–1.87]) were not statistically different between treatment groups.CONCLUSIONS:In patients with M2 occlusion in the 6- to 24-hour time window, there was no difference in disability outcomes or symptomatic intracranial hemorrhage risk between patients treated with EVT compared with MM. Results of ongoing randomized trials will provide further insight.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT04096248.

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Objective
To determine wealth-based inequality and the dropout rate in the completion of the maternal continuum of care (CoC) in Ethiopia.

Setting
Ethiopian Demographic and Health Survey-2019.

Participants
Reproductive-age women (15–49 years) in Ethiopia.

Primary outcome
Completion of the maternal CoC services is the primary outcome. Maternal CoC is defined as a situation where women have at least four antenatal care (ANC) visits, deliver their babies at a health facility and receive at least one postnatal care service for both mother and newborn baby.

Methods
We analysed the 2019 Mini demographic and health survey data using STATA V.17. Multilevel logistic regression analysis was employed for the factors associated with the maternal CoC. The concentration index was used to measure equity.

Result
Overall, 24% (95% CI: 21.6 to 26.5) of women completed the maternal CoC. There was wealth-based inequality in the completion of maternal CoC in Ethiopia (concentration index: 0.25 (95% CI: 0.18 to 0.31, p≤0.001)), rural residents (concentration index: 0.15 (95% CI: 0.09 to 0.21, p≤0.001)) and urban residents (concentration index: 0.15 (95% CI: 0.05 to 0.26, p≤0.01)). Being an urban resident (adjusted OR (AOR)=1.59, 95% CI: 1.09 to 2.33), attaining secondary (AOR=1.67, 95% CI: 1.19 to 2.33) or higher education (AOR=1.93, 95% CI: 1.30 to 2.87) and early initiation of ANC (AOR=1.97, 95% CI: 1.61 to 2.41) were positively associated with the completion of maternal CoC. However, belonging to a pastoral region (Afar or Somali) (AOR=0.46, 95% CI: 0.28 to 0.77), belonging to the poorest (AOR=0.58, 95% CI: 0.37 to 0.92) or middle (AOR=0.62, 95% CI: 0.40 to 0.96) wealth quintile, not being informed about obstetric danger signs (AOR=0.54, 95% CI: 0.43 to 0.66) and blood pressure not being measured (AOR=0.53, 95% CI: 0.32 to 0.85) were negatively associated with maternal CoC.

Conclusion
We concluded that completion of the maternal CoC was low in Ethiopia. There was significant inequality in the completion of maternal CoC across wealth status, place of residence and educational status. Strategies and interventions that target the disadvantaged group of women are needed to improve the utilisation of maternal healthcare services. Tailored and multisectoral intervention considering women with poor or middle wealth, women in pastoralist regions and women with no information on obstetric danger signs improves the CoC practice in the country.

Introduction
The effects of bariatric surgery have largely been studied from a medical viewpoint, seeking to measure changes in anthropometric, physiological or quality-of-life factors after the operation. Few studies, however, have focused on the dynamics of lifestyle changes. Yet we know that changing lifestyle habits—which are often part of the established social configurations at the origin of morbid obesity—is essential for a sustainable recovery from obesity. We also know that the major bodily transformations that occur in the six to twelve months following surgery produce a high degree of biographical uncertainty and affect social interactions. From a sociological perspective, the authors propose to study the processes of disruption and re-establishment of lifestyle habits in the first 24 months following bariatric surgery.

Methods and analysis
The ChiBarAPS study relies on a mixed-method longitudinal survey, comprising three components: qualitative, quantitative, literature and data review. It aims to document three main dimensions, which must be articulated to understand the dynamics of change: (1) the work undertaken by patients on themselves in order to identify and measure the evolutionary effects of surgery, as well as to adapt to them; (2) the experience of using pre- and post-surgery information and support systems, and evaluating their effects on the agency of the people who have undergone surgery; (3) the evolution of social participation and lifestyle habits. The qualitative component concerns a cohort of 30 patients, interviewed in depth (2 hours) on these three dimensions, 6 months, 12 months and 24 months after the operation. The quantitative part uses questionnaires applied to a second group of 200 patients, following the same timeline.

Ethics and dissemination
This study complies with reference methodology MR004 of the French National Data Protection Authority and was registered by the Data Protection Officer of the University of Montpellier on the activity registry of the institution (24 April 2024). Ethics approval has been obtained from the University of Montpellier ethics research board (n°UM2024-037). Informed consent will be obtained from all participants before data collection. The project has received funding from the French National Research Agency (n°ANR-23-CE41-0020-01) from February 2024 to the end of January 2028. The first results of the research will be disseminated from 2026 onwards to researchers, health professionals and patient support organisations. The results of the study will then be published in peer-reviewed scientific journals, both national and international.

Stroke, Ahead of Print. BACKGROUND:Hemorrhagic transformation (HT) frequently occurs in acute ischemic stroke patients with a large vessel occlusion undergoing endovascular therapy (EVT), significantly impacting functional outcomes. We aimed to determine whether an early fibrinogen depletion coagulopathy (FDC) was associated with HT following bridging therapy (ie,intravenous thrombolysis [IVT] followed by EVT), and to identify its associated factors.METHODS:We retrospectively analyzed prospectively collected data from 296 patients with acute ischemic stroke with a large vessel occlusion who underwent EVT alone or bridging therapy, with fibrinogen levels measured both before baseline imaging and at the start of the EVT procedure. FDC was defined as a fibrinogen level 1.0 g/L from baseline. The primary outcome was the occurrence of any HT at 24 to 36 hours. Secondary outcomes included symptomatic HT, parenchymal hematomas, and 3-month mortality. The relationships between FDC and outcomes were studied using multivariable logistic regression analyses, adjusting for relevant confounders. We also studied baseline characteristics associated with FDC occurrence.RESULTS:Of the 296 patients enrolled, 102 (34.5%) experienced HT, and 54 (18.2%) developed FDC. FDC was strongly associated with IVT use (53/161 [32.9%] versus 1/135 [0.7%] in IVT-treated and non-IVT-treated patients, respectively;P

Stroke, Ahead of Print. BACKGROUND:Early initiation of direct oral anticoagulants (DOACs) in patients with nonvalvular atrial fibrillation and acute ischemic stroke is beneficial and safe. Whether prior acute reperfusion therapy modifies the treatment effect of early versus late DOAC initiation is unknown.METHODS:For this post hoc analysis of the multicenter, randomized controlled ELAN trial (Early Versus Late Initiation of Direct Oral Anticoagulants in Post-Ischaemic Stroke Patients With Atrial Fibrillation), all participants with data concerning reperfusion treatment were included. The primary outcome was the composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, major extracranial bleeding, systemic embolism, or vascular death within 30 days. Patients were divided into 4 groups based on prior reperfusion therapy: no treatment, intravenous thrombolysis (IVT), endovascular treatment (EVT), or IVT combined with EVT. We performed logistic regression adjusted for age, hypertension, infarct location/size, pre-modified Rankin Scale, NIHSS, and hemorrhagic transformation, including the interaction term between treatment groups (early versus late DOAC) and reperfusion strategy.RESULTS:We included 1973 of 2013 (98%) patients of the ELAN trial population, with a median age of 77 (71–84) years and of whom 899 (46%) were female. Of them, 1015 (51%) underwent no prior reperfusion treatment, 519 (26%) IVT, 190 (10%) EVT, and 249 (13%) IVT+EVT. We did not identify an interaction for any of the outcome events between prior reperfusion therapy and timing of DOAC initiation. Rates were numerically lower in the early DOAC-initiated group for the following: no reperfusion therapy, 17 (3.3%) versus 24 (4.8%; adjusted odds ratio, 0.69 [95% CI, 0.36–1.28]); EVT, 1 (1.2%) versus 7 (6.4%; adjusted odds ratio, 0.25 [95% CI, 0.03–1.21]); and EVT+IVT, 3 (2.4%) versus 4 (3.3%; adjusted odds ratio, 0.76 [95% CI, 0.17–3.23]). In patients who had received IVT, the rates were 3% (n=8) in the early group versus 2% (n=5) in the late group (adjusted odds ratio, 1.52 [95% CI, 0.52–4.84]).CONCLUSIONS:Prior reperfusion therapy does not modify the effect of early versus late DOAC initiation on clinical outcomes in patients with atrial fibrillation and acute ischemic stroke.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT03148457.

Objectives
To update our previous systematic review to synthesise latest data on the prevalence of long-term pain in patients who underwent total hip replacement (THR) or total knee replacement (TKR). We aim to describe the prevalence estimates and trends in this review.

Design
Systematic review and meta-analysis.

Data sources
Update searches were conducted in MEDLINE and Embase databases from 1 January 2011 to 17 February 2024. Citation tracking was used to identify additional studies.

Eligibility criteria
We included prospective cohort studies reporting long-term pain after THR or TKR at 3, 6, 12 and 24 months postoperative.

Data extraction and synthesis
Two reviewers independently identified studies as eligible. One reviewer conducted data extraction, checked by a second reviewer. The risk of bias assessment was performed using Hoy’s checklist. Bayesian, random-effects meta-analysis was used to synthesise the results.

Results
For TKR, 68 studies with 89 time points, including 598 498 patients, were included. Multivariate meta-analysis showed a general decrease in pain proportions over time: 21.9% (95% CrI 15.6% to 29.4%) at 3 months, 14.1% (10.9% to 17.9%) at 6 months, 12.6% (9.9% to 15.9%) at 12 months and 14.6% (9.5% to 22.4%) at 24 months. Considerable heterogeneity, unrelated to examined moderators, was indicated by substantial prediction intervals in the univariate models. Substantial loss to follow-up and risk of bias led to low confidence in the results. For THR, only 11 studies were included, so it was not possible to describe the trend. Univariate meta-analysis estimated 13.8% (8.5% to 20.1%) and 13.7% (4.8% to 31.0%) of patients experiencing long-term pain 6 and 12 months after THR, respectively, though concerns in risk of bias results reduced confidence in these findings.

Conclusions
Our review suggests that approximately 22% of patients report pain 3 months post-TKR, with 12%–15% experiencing long-term pain up to 2 years. At least 14% report pain 6–12 months after THR. Given the prevalence of chronic postsurgical pain, implementing existing and developing new preventive and management strategies is crucial for optimal patient outcomes.

PROSPERO registration number
CRD42023475498.